Devices

Device Recall Gemini TF 16 PET/CT; Gemini RF 64 PET/CT; Gemini TF Big Bore

Model / Serial
GEMINI TF PET/CT16: 882470 7019,7039,7099,7588,7593,7598,7599,7600,7604,7605,7596M GEMINI TF PET/CT 64: 882471 7027,7044,7146,7153,7178,7182,7188,7578,7579,7585,7587,7589,7592,7594,7595,7602, 7603, 7606 GEMINI TF Big Bore: 882476 9019,9227,9232,9233
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Distributed in the states of CA, CO, IL, OK, OR and WI.
Product Description
GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: 882476. A diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Manufacturer
Philips Medical Systems (Cleveland) Inc
1 Event
- Recall of Device Recall Gemini TF 16 PET/CT; Gemini RF 64 PET/CT; Gemini TF Big Bore

Manufacturer

Philips Medical Systems (Cleveland) Inc

Manufacturer Address
Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
Manufacturer Parent Company (2017)
Philips
Source
USFDA

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